Roche Reports Sustained Vision and Anatomical Improvements with Vamikibart at 52 Weeks

Roche reports 52-week Phase III findings for vamikibart in uveitic macular edema, with sustained vision improvements and limited retreatment needs.

Roche announced on October 10, 2026, new 52-week findings from the Phase III MEERKAT and SANDCAT trials evaluating investigational vamikibart in adults with uveitic macular edema (UME). The studies compared intravitreal (IVT) vamikibart with a sham procedure designed to mimic an injection. The findings were presented at the American Academy of Ophthalmology (AAO) 2026 Annual Meeting in New Orleans.

Across both studies, a numerically higher proportion of patients receiving vamikibart achieved a gain in vision at week 52 than those receiving sham treatment. Roche also reported that improvements in best-corrected visual acuity (BCVA) and central subfield thickness (CST), an imaging measure used to assess retinal swelling, were maintained through one year.

The results extend the initial 16-week analyses reported in 2025, but the distinction between the original primary endpoint and the later follow-up is important. The primary endpoint was assessed at week 16. The week 52 findings provide information on longer-term outcomes and retreatment, rather than representing a new primary-endpoint assessment.

Original Phase III results provide important context

MEERKAT and SANDCAT were designed with the same trial framework, but their initial primary-endpoint results were not identical: vamikibart met the week 16 primary endpoint in MEERKAT, whereas SANDCAT did not achieve statistical significance for that endpoint. The one-year findings add evidence about the persistence of visual and anatomical improvements, but should be interpreted alongside those original results.

Roche’s public summary of the week 52 findings describes the direction of the results but does not provide the detailed numerical estimates needed to compare the size of treatment effects between groups. The reported findings therefore support a durability signal, but the announcement alone does not allow a full assessment of the magnitude or precision of the week 52 differences.

Addressing inflammation in a sight-threatening condition

UME develops when inflammation associated with uveitis causes fluid to accumulate in the macula, the central region of the retina responsible for detailed vision. It is a major cause of moderate-to-severe vision loss among people with uveitis and can interfere with daily activities such as reading and driving. The condition predominantly affects working-age adults.

Treatment commonly involves corticosteroids administered locally or systemically, alongside other therapies that may be used off-label. Although corticosteroids can control inflammation, prolonged exposure can increase the risk of cataracts and elevated intraocular pressure, which may lead to glaucoma.

Vamikibart is an investigational monoclonal antibody engineered for intravitreal administration. It targets interleukin-6 (IL-6), a cytokine involved in inflammatory pathways associated with UME. The approach is being studied as a targeted, non-steroidal treatment option; its clinical role will depend on the complete evidence package and regulatory review.

MEERKAT and SANDCAT trial design

MEERKAT (NCT05642312) and SANDCAT (NCT05642325) are global, multicentre, randomised, double-masked, sham-controlled Phase III trials conducted over 52 weeks. Both studies evaluated intravitreal vamikibart at doses of 0.25 mg and 1 mg against sham injections.

Participants received treatment every four weeks for up to 16 weeks, followed by as-needed (PRN) treatment through week 52. The primary endpoint was the proportion of participants achieving an improvement of at least 15 letters from baseline in BCVA at week 16. Key secondary endpoints included mean changes from baseline in BCVA and CST at week 16.

The 52-week assessment helps evaluate whether improvements seen during the initial treatment period persist and how much additional treatment patients may require. However, interpretation of long-term outcomes should account for the trial’s retreatment approach and the absence of detailed numerical week 52 comparisons in Roche’s summary announcement.

Retreatment requirements and safety

Roche reported that approximately two-thirds of eligible patients required no retreatment after week 16. Among patients who received additional treatment, the majority required only one further injection. This suggests that many eligible patients may maintain benefit without frequent additional injections after the initial treatment period, although retreatment needs may vary between individuals.

Vamikibart was reported to be well tolerated through the study period, with a favourable safety profile and a low incidence of treatment-related ocular adverse events and intraocular inflammation. Safety assessments also included retinal occlusive vasculitis. The company announcement does not provide detailed event counts for the one-year findings, so individual adverse-event rates should not be inferred from the summary release. The full conference presentation is the appropriate source for further numerical safety detail.

Regulatory progress and clinical outlook

The US Food and Drug Administration has accepted Roche’s biologics license application (BLA) for vamikibart in UME, based on the MEERKAT and SANDCAT results. The FDA is expected to make an approval decision by July 2027. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.

If approved, vamikibart could become the first targeted non-steroidal treatment for UME. That possibility remains contingent on regulatory decisions and the complete assessment of efficacy and safety. Vamikibart remains investigational and is not currently approved for this indication.

What the findings mean

The week 52 findings suggest that improvements in vision and macular thickness can be maintained with vamikibart, while many eligible patients require limited retreatment after week 16. The limited retreatment requirement may be clinically relevant in a condition that can require prolonged management. However, the available company summary does not provide enough numerical detail to quantify the size of the week 52 treatment effect or fully assess between-group differences. The original week 16 primary-endpoint results also remain important to interpreting the overall Phase III evidence.

References

Roche presents new Phase III one-year data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss. Roche, October 10, 2026

Acharya N, et al. Vamikibart for Uveitic Macular Edema: Week 52 Efficacy and Safety Results from the Phase 3 MEERKAT and SANDCAT Trials. Presented at the American Academy of Ophthalmology Annual Meeting (AAO 2026), October 10, 2026

Khurana RN, et al. Follow-up on MEERKAT and SANDCAT Trials on Vamikibart for Uveitic Macular Edema. Presented at the American Academy of Ophthalmology Annual Meeting (AAO 2026).

ClinicalTrials.gov. MEERKAT: NCT05642312

ClinicalTrials.gov. SANDCAT: NCT05642325